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An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)

The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a
third-line and later treatment for subjects with relapsed or refractory delta-like protein 3
(DLL3) expressing small cell lung cancer (SCLC).

7. Subjects with a history of central nervous system (CNS) metastases must have
documentation of stable or improved status based on brain imaging for at least 2 weeks
after completion of definitive treatment and within 2 weeks prior to first dose of
Study Drug, off or on a stable dose of corticosteroids.

11. Females of childbearing potential must have a negative beta human chorionic
gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of
study drug. Females of non-childbearing potential are those who are postmenopausal
greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

Exclusion Criteria:

1. Any significant medical condition, including any suggested by screening laboratory
findings that, in the opinion of the investigator or sponsor, may place the subject at
undue risk from the study, including but not necessarily limited to uncontrolled
hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic
obstructive pulmonary disease requiring hospitalization within 6 months) or
neurological disorder (e.g., seizure disorder active within 6 months)

2. Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of
study drug

3. Recent or ongoing serious infection, including:

- Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or
fungal infection within 2 weeks of the first dose of the study drug. Routine
antimicrobial prophylaxis is permitted.

- Known seropositivity for or active infection by human immunodeficiency virus
(HIV)

5. Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1
week prior to the first dose of study drug

6. History of another invasive malignancy that has not been in remission for at least 3
years. Exceptions to the 3 year limit include nonmelanoma skin cancer, curatively
treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous
intraepithelial lesion on PAP smear

7. Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity
to rovalpituzumab tesirine or excipient contained in the drug formulation, unless
undergoing retreatment with rovalpituzumab tesirine in the context of this protocol